Baxter Recalls Sevoflurane Inhalation Anesthetic Due to Failed Stability Specifications
Baxter Healthcare is recalling 5,940 bottles of Sevoflurane inhalation anesthetic because the product failed stability specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Baxter Healthcare Corporation is recalling 5,940 bottles of Sevoflurane, USP Inhalation Anesthetic, 250 mL bottles. The product is a prescription-only medication manufactured for Baxter Healthcare Corporation in Deerfield, IL, with NDC 10019-651-64. The specific lot affected is S110F822, with an expiration date of 5/31/2021.
The recall was initiated because the product failed stability specifications. The affected product was distributed nationwide within the United States. No specific illnesses or injuries are reported in the source text.
Healthcare providers and patients should stop using the affected lot of Sevoflurane and contact Baxter Healthcare Corporation for further instructions or a replacement.
The recalled product
- Product
- SEVOFLURANE (SEVOFLURANE)
- Brand
- SEVOFLURANE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Inhalation Anesthetic
- Hazard
- Affected units
- 5,940
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: S110F822 Exp. 5/31/2021
UPCs (1)
- 0310019651644
Distribution
Distributed nationwide across the United States.
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